AstraZeneca received the EU approval for AXANUM
AstraZeneca today announced that AXANUM, a fixed dose combination of 81 mg low-dose ASA (acetylsalicylic acid) and 20 mg esomeprazole (Nexium), has received positive agreement for approval in 23 European Union member countries and in Norway.
AXANUM once-daily pill is a combination of low-dose ASA 81mg and esomeprazole 20mg.
Esomeprazole, which is the active ingredient in the proton pump inhibitor (PPI) Nexium, is approved for the risk reduction of peptic ulcer development in low-dose ASA patients and is the only PPI approved for the risk reduction of re-bleeding in peptic ulcer bleed patients.
AXANUM is indicated for prevention of cardiovascular (CV) events such as heart attack or stroke, in high-risk CV patients in need of daily low-dose ASA treatment and who are at risk of gastric ulcers.
Low-dose ASA (commonly known as aspirin) is recommended mainstay therapy for patients with high-risk for cardiovascular events. About one third of these patients are also at increased risk of gastro-duodenal ulcer. Low-dose ASA further increases the risk for gastric ulcers and gastrointestinal bleeding. In fact, the most common reason for stopping low-dose ASA treatment is upper gastrointestinal problems. The consequences of interrupting low-dose ASA treatment can be severe, increasing the risk of a heart attack or stroke as early as eight to 10 days later.
AXANUM is the only medicine that ensures every single pill of low-dose ASA comes with built-in protection against gastric ulcers.
That means AXANUM has the potential to provide continuous CV protection in this patient population.
The EU decision took place under the decentralized procedure (DCP), with Germany acting as reference member state. This process is now followed by national approvals and local pricing and reimbursement discussions.
AstraZeneca submitted a Marketing Authorization Application in the EU via the Decentralized Procedure for AXANUM on 30 April 2009. The EU Concerned Member States include: Austria; Belgium, Denmark, Luxemburg, Bulgaria, Cyprus, Czech Republic, Estonia, Germany, Greece, Finland, France, Italy, Lithuania, Latvia, Malta, Netherlands, Poland, Portugal, Romania, Sweden, Slovenia and Norway. The Member States will now work to pursue pricing/reimbursement and national approvals.
In 2010, AstraZeneca has obtained a complete response letter (CRL) from FDA for its new drug application Axanum.
Additionally it has also received a CRL for the supplemental new drug application (sNDA) for Nexium (esomeprazole magnesium).
AstraZeneca is currently evaluating the CRLs, and will continue discussions with the FDA to determine next steps with respect to both the AXANUM NDA as well as the NEXIUM sNDA and will respond to the agency’s request for additional information.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
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